HANDI OXYGEN ANALYZER

K973282 · Ceramatec, Inc. · CCL · Mar 4, 1998 · Anesthesiology

Device Facts

• Record ID: K973282
• Device Name: HANDI OXYGEN ANALYZER
• Applicant: Ceramatec, Inc.
• Product Code: CCL · Anesthesiology
• Decision Date: Mar 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1720
• Device Class: Class 2

Intended Use

The intended use of the Ceramatec® Handi oxygen analyzer is to monitor the oxygen concentration in the patient-breathing environment.

Device Story

Ceramatec Handi is a portable oxygen analyzer for monitoring oxygen concentration in patient breathing environments. Device utilizes a galvanic fuel-cell sensor containing a lead anode and gold oxygen cathode with aqueous electrolyte; oxygen permeating a fluoropolymer membrane reduces at the gold electrode, generating a millivolt output proportional to oxygen partial pressure. An internal electronic circuit with temperature-compensating thermistors converts this signal to a digital percent-oxygen reading on an LCD. Operated via an 'ON' button; features auto-off after 1.3 minutes and low-battery detection. Calibration is performed via a potentiometer against known gas concentrations. Used by clinicians or patients in clinical or home settings to ensure appropriate oxygen levels; output provides direct visual feedback for clinical decision-making regarding oxygen therapy management.

Clinical Evidence

No clinical data. Bench testing only. Performance verified through accuracy (±3% full-scale), linearity (±2% full-scale), and response time (<15 seconds) testing.

Technological Characteristics

Galvanic fuel-cell sensor; gold cathode, lead anode, fluoropolymer membrane. Housing: corrosion-resistant plastic. Power: lithium button-cell battery. Display: 2-digit LCD. Connectivity: none. Calibration: manual potentiometer. Temperature compensation: internal thermistor network. Dimensions: 3 oz weight.

Indications for Use

Indicated for patients requiring monitoring of oxygen concentration in their breathing environment. No specific age or gender restrictions; contraindicated only if environmental conditions fall outside 10-40°C or 0-95% relative humidity.

Regulatory Classification

Identification

An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.

Predicate Devices

• MSA Miniox® IA oxygen analyzer (K935370)

Submission Summary (Full Text)

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14713282

- August 28, 1997 2.0 Submitter: Ceramatec, Inc. 2425 South 900 West Salt Lake City, Utah 84119 3.0 Contact Person: Gordon Roth Quality System Manager 4.0 Telephone: [phone] Phone Direct: [phone] Phone Business: [phone] FAX 5.0 Proprietary Device Name: Ceramatec® Handi 6.0 Classification Name: Oxygen Gas Analyzer 7.0 Common Name: Oxygen Analyzer 8.0 Predicate Device: MSA Miniox® IA oxygen analyzer (K935370)
#### 9.0 Device Function:

Date:

1.0

The device function of the Ceramatec Handi oxygen analyzer is to monitor oxygen concentration in the patient environment.

MAR - 4 1998

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#### Method of Operation: 10.0

The Ceramated Handi oxygen analyzer is comprised of a galvanic oxygen sensor and an analyzer module. The galvanic oxygen sensor produces a millivolt output that is proportional to the partial pressure of oxygen in the monitored gas. The analyzer module contains an electronic circuit that converts the millivolt output of the sensor to a digital percent-oxygen reading on a liquid-crystal display (LCD).

The electronic circuit includes an "ON" button, a calibration potentiometer, and a two-digit LCD. The "ON" button is used to power-on the instrument. The LCD is blank when the Handi is in power-off mode. When the "ON" button is pressed, the unit begins to display the percent-oxygen concentration of the monitored gas. The unit is equipped with an auto-off circuit that automatically turns the device off approximately 1.3 minutes after power-on. The device also contains a low-battery detection circuit to safeguard against faulty readings due to a low-battery condition. When a low-battery condition is detected, the low-battery detection circuit prevents operation of the device by immediately powering-down the analyzer upon release of the "ON" button.

The calibration potentiometer allows the device to be calibrated against a gas of a known oxygen concentration, such as air (21% oxygen) or 99% oxygen. The two-digit LCD provides direct readout of percent-oxygen concentration. An over-range indication is included on the LCD to differentiate between 0% oxygen and 100% oxygen.

Please find the attached flow-diagram illustrating the operation of the Ceramatec® Handi oxygen analyzer.

The galvanic oxygen sensor is a lead-oxygen battery consisting of a lead anode, and an oxygen cathode. The oxygen cathode is made up of gold and an aqueous electrolyte solution. The gold electrode is in close proximity to a non-porous fluoropolymer membrane. Oxygen permeating through the membrane is reduced electrochemically at the gold electrode. An electronic network, consisting of resistors and / or thermistors for temperature compensation, is connected between the cathode and anode. This allows the lead-oxygen battery to continually discharge in the presence of oxygen. The voltage across the resistor / thermistor network is proportional to the oxygen partial pressure of the gas in contact with the fluoropolymer membrane. This voltage is converted by the analyzer to a digital output that is displayed on the LCD.

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#### 11.0 Materials of Construction:

| Corrosion-Resistant Plastic: | Housing |
|-----------------------------------|-----------------------|
| LCD: | Display |
| Potentiometer: | Calibration |
| Epoxy-Resin Circuit Board: | Printed Circuit Board |
| Lithium Battery: | Power Source |
| Galvanic Fuel-Cell Oxygen Sensor: | Sensor |

#### 12.0 Product Specifications:

| PRODUCT | CERAMATEC® HANDI |
|-----------------------------|---------------------------------------------|
| Display Range | 0-99% oxygen |
| Display Resolution | 1% oxygen |
| Warm-up time | none required |
| Operating Temperature Range | 10 - 40°C |
| Operating Humidity Range | 0-95% RH non-condensing |
| Accuracy | $\pm$ 3% full-scale |
| Linearity | $\pm$ 2% full-scale |
| Sensor type | galvanic fuel sensor 0-100% O2 |
| Sensor Operating Life | 12 months under normal operating conditions |
| Sensor Shelf Life | 6 months |
| Storage Temperature | -15° - 50 °C |
| 90% FS Response Time | <15 Seconds @ 25 °C |
| Interference | $\pm$ 2% full-scale |
| Low-Battery Indicator | instantaneous shut-off |
| Power Requirement | lithium button-cell battery |
| Battery Life | 1100 hours |
| Instrument Weight | approximately 3 ounces |

#### 13.0 Intended Use:

The intended use of the Ceramatec® Handi oxygen analyzer is to monitor the oxygen concentration in the patient-breathing environment.

### Patient Population: 14.0

The patient population of the Ceramatec Handi oxygen analyzer consists of those patients who require the oxygen concentration in their environment to be monitored.

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| PRODUCT | MSA MINIOX® IA | CERAMATEC® HANDI |
|-----------------------------|------------------------------------------------|-----------------------------|
| Display Range | 0-100% oxygen | 0-99% oxygen |
| Display Resolution | 0.1% oxygen | 1% oxygen |
| Warm-up time | none required | same |
| Operating Temperature Range | 0 - 40°C | 10 - 40 °C5 |
| Operating Humidity Range | 0-95% RH non-condensing | same |
| Accuracy | ±3% full-scale6 | same |
| Linearity | ±2% full-scale | same |
| Sensor type | galvanic fuel sensor 0-100% O2 | same |
| Sensor Operating Life | 12 months under normal operating<br>conditions | same |
| Sensor Shelf Life | 6 months | same |
| Storage Temperature | -20 - 55 °C | -15° - 50 °C |
| 90% FS Response Time | <15 Seconds @ 25 °C | same |
| Interference | ±2.3% full-scale | ±2% full-scale |
| Low-Battery Indicator | LO BAT appears on LCD | instantaneous shut-off |
| Power Requirement | 9 V alkaline battery | lithium button-cell battery |
| Battery Life | 1400 hours | 1100 hours |
| Instrument Weight | 11 ounces | approximately 3 ounces |

#### Comparison of Technological Characteristics: 15.0

#### 16.0 Conclusion:

In conclusion, based on the information provided, it has been determined that the Ceramatec Handi oxygen analyzer is substantially equivalent to MSA Miniox IA oxygen analyzer is safe and effective for its intended use.

Since the patient breathing-environment is a controlled environment, oxygen analyzers are not typically exposed to temperatures between 0 - 10 °C. ANSI Z79.10 Section 3.2.3.1 specifies that an oxygen analyzer used in a patient breathing environment shall be capable of operating in a temperature range of 15-40 °C. The operating temperature range of the Handi is well within the ANSI specification. Therefore the operating temperature and relative humidity specifications of the Ceramated Handi oxygen analyzer and the predicate device are equivalent.

⁶ Calculated per temperature effects in MSA Operating Manual, page 5-3.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 1998

Mr. Gordon Roth Quality Systems Manager Ceramatec Inc. 2425 South 900 West Salt Lake City, UT 84119

Re: K973282 Handi Oxygen Analyzer Regulatory Class: II (two) Product Code: 73 CCL December 5, 1997 Dated: Received: December 8, 1997

Dear Mr. Roth:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is a man substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will Verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510K Number (if known) :

Device Name: Ceramatec Handi Oxygen Analyzer

Indication for Use:

Purpose: The purpose of the Ceramatec Handi oxygen analyzer is to monitor oxygen concentration in the patient breathing environment.

Function: The Ceramatec" Handi oxygen analyzer measures the oxygen partial pressure of a gas stream, and displays a digital reading of the oxygen concentration of the measured gas on a liquid-crystal display (LCD).

Target Patient Population: The target patient population consists of patients who require the oxygen concentration in their environment to be monitored.

Environment of Use: The Ceramatec Handi oxygen analyzer is used in patient breathing environments whose temperatures range from 10 to 40 ℃, and whose relative humidity ranged from 0 - 95% (non-condensing).

Device Claims: The Ceramatec Handi oxygen analyzer has the claim of monitoring percentoxygen concentration in the patient breathing environment.

Legally Marketed Predicate Device: The legally marketed predicate device is the MSA Miniox® IA oxygen analyzer. The predicate device was assigned 510(k) number K935370 and declared substantially equivalent by FDA.

Safety and Effectiveness: No differences in intended use or application of the Ceramated Handi or MSA Miniox IA have been identified that could affect product safety or effectiveness.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-------------------------------------------------------------------|---------|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K973282 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

(Optional Format 1-2-96)